NASCO Products LLC – FDA EIR, Jun 5, 2018

An FDA inspection of NASCO Products, LLC, a cigar and cigarette manufacturer located in Mocksville, NC, took place on June 5, 2018. The company operates under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. The inspection focused on the manufacturing, labeling, and quality control procedures for cigar products. While no major sanitation deficiencies were identified and a Form FDA 483, Inspectional Observations, was not issued during this visit, several areas for procedural enhancement were noted. These included the absence of a formal, documented employee training program, with all training and operational procedures remaining in draft form. Furthermore, the firm lacked written procedures for managing non-conforming products, consumer complaints, and product recalls. During the close-out meeting, management was reminded of their responsibility to submit marketing information by the compliance deadline and was requested to provide updated product labeling to the Center for Tobacco Products (CTP).